Device and method for the therapy of obesity

ABSTRACT

An anastomotic device, particularly a positioning device ( 24 ) extending along a longitudinal axis ( 30 ) comprises a first component, or proximal component ( 26 ) and a second component, or distal component ( 28 ). The proximal and distal components are suitable to lock an elastic ring ( 52 ) in a deformed configuration therebetween. The proximal component ( 26 ) has a substantially cylindrical outer structure with a cavity ( 32 ) for receiving a proximal end ( 52   a ) of the elastic ring ( 52 ). The distal component ( 28 ) comprises a head ( 42 ) and a stem ( 44 ) developing along the longitudinal axis ( 30 ). The head ( 42 ) has a cone or truncated-cone shape.

FIELD

The present invention relates to devices and methods for the therapy ofobesity in general. Particularly, the present invention relates todevices for drawing together tissues that are suitable to be used in amethod for carrying out anastomosis in tracts of the digestive tube.

The present invention further relates to a method for carrying outanastomosis in tracts of the digestive tube.

BACKGROUND

At present, surgical anastomoses are very difficult to carry out viaendoluminal access. Most of anastomoses, in fact, are created by usingopen or laparoscopic surgical techniques.

Accordingly, no effective surgical instruments are available which offerthe guide and control required to suitably drawing together the tissuesurfaces and/or connecting the surfaces with a passage (anastomosis)through the body cavities.

The problem at the heart of the present invention is to provide devicescapable of drawing tissues together and create a passage therebetween. Afurther problem at the heart of the present invention is to providedevices capable of being used in a method for carrying out anastomosisin tracts of the digestive tube with endoluminal access.

This problem is solved by means of a device for drawing together tissuesin accordance with claim 1.

According to a still further aspect, a problem at the heart of thepresent invention is to provide a method for carrying out anastomoses intracts of the digestive tube with endoluminal access.

DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the devices, circular staplerand method according to the invention will result from the descriptionbelow of preferred exemplary embodiments, which are given as anon-limiting indication, with reference to the attached figures,wherein:

FIG. 1 illustrates a perspective view of a circular stapler;

FIG. 2 illustrates a perspective view of a device to be associated withthe circular stapler from FIG. 1;

FIG. 2 a illustrates a perspective view of the stapler from FIG. 1,guide wire and device from FIG. 2 during an assembly step for performinga suture;

FIG. 3 illustrates a perspective view of a possible embodiment of apositioning device;

FIG. 4 illustrates a sectional view along a plane containing alongitudinal axis of the device from FIG. 3;

FIG. 5 illustrates a perspective view of a detail of the device fromFIG. 3;

FIG. 6 illustrates a perspective view of a detail of the device fromFIG. 3;

FIGS. 7 and 8 illustrate perspective views of the detail from FIG. 5from different points of view;

FIG. 9 illustrates a perspective view of a possible embodiment of apositioning device;

FIG. 10 illustrates a sectional view along a plane containing alongitudinal axis of the device from FIG. 9;

FIG. 11 illustrates a partially sectioned, perspective view of a detailof the device from FIG. 9;

FIG. 12 illustrates a perspective view of a detail of the device fromFIG. 9;

FIG. 13 illustrates a perspective view of a possible embodiment of apositioning device;

FIG. 14 illustrates a sectional view along a plane containing alongitudinal axis of the device from FIG. 13;

FIG. 15 illustrates a perspective view of a detail of the device fromFIG. 13;

FIG. 16 illustrates a perspective view of a detail of the device fromFIG. 13;

FIGS. 17-40 illustrate several steps of a method according to thepresent invention;

FIG. 41 illustrates a partial perspective view of a circular stapler, apositioning device and a guide wire, an anchoring ring being insertedthereon;

FIG. 42 illustrates the circular stapler, positioning device and guidewire from FIG. 41 while the positioning device is being inserted in thecircular stapler;

FIG. 43 illustrates the FIG. 41 in a longitudinal section;

FIG. 44 illustrates FIG. 41 from a different point of view.

DETAILED DESCRIPTION

With reference to FIG. 1, with 10 has been indicated a circular staplerportion comprising a handle 12 and a stem 14 as a whole. The structureof the circular stapler is similar to the known circular staplers, whichare conventionally used to carry out circular anastomosis, such as ofthe bowel. The structure of the circular stapler from FIG. 1 is changedcompared with the conventional ones in that, in a preferred embodimentthereof, it has a channel suitable to receive the guide wire. In FIG.2A, the circular stapler 10 has a channel crossing the stem 14 thereoffrom the distal end to an area at the proximal end from which itprotrudes outside, for example on one side. In accordance with differentembodiments, not illustrated, the guide wire runs all along the lengthof the circular stapler or only a distal portion thereof.

The channel is suitable to receive a guide wire (not illustrated inFIG. 1) such that the stapler can slide therealong and be placed in thesite requiring anastomosis. An exemplary use of the circular stapler 10will be described below with particular reference to FIG. 29. The lengthof the stem 14 and the diameter thereof are sufficient to carry out themethod and reach the desired site.

Advantageously, the stem is made of a flexible material, such as tofacilitate reaching the site requiring anastomosis.

The stapler 10 advantageously comprises an anvil 16 illustrated forexample in FIG. 2. The anvil 16 defines an exemplary device for drawingtissues together, particularly a device that, besides drawing thetissues together, is suitable to be associated with the circular anvil10 such as illustrated in FIG. 1 in order to carry out anastomosis.

The anvil 16 comprises a stem 18 and a head 20. The stem 18 has such alongitudinal and cross size that makes it suitable to be fit on the endof the stem 14 of the circular stapler 10 opposite the handle 12 (FIGS.2A and 41-44).

Advantageously, a channel 22 crosses the anvil 16 in a longitudinaldirection and is suitable to receive a guide wire, not illustrated inFIG. 2. An exemplary use of the anvil 16 for the circular stapler 10will be described below with particular reference to FIGS. 26-29. Ananchoring ring suitable to lock the anvil 16 on the guide wire on whichit is fitted such as to be drawn by the guide wire in order to draw thetissues together and create the anastomosis has been designated with 76.

With reference to FIG. 3, with 24 has been generally indicated apositioning device according to the present invention. In other words,in FIG. 3 there is illustrated a positioning device suitable to drawtissues together which have been subjected to enterostomy, and to placemeans for providing a passage (anastomosis) between the tissues thathave been drawn together.

The positioning device 24 comprises a first component, or proximalcomponent, designated with numeral 26 and a second component, or distalcomponent, designated with reference 28. Preferably, the positioningdevice 24 extends along a longitudinal axis 30. FIGS. 5, 7 and 8illustrate perspective views of the proximal component 26, whereas FIG.6 illustrates a perspective view of the distal component 28.

In accordance with a possible embodiment, the proximal component 26 issuitably shaped to be abutted against the edge of a first enterostomy inorder to draw the tissues adjacent thereto against the tissues adjacentto a second enterostomy. The distal component 28 is suitably shaped tobe inserted through the enterostomies.

For clarity purpose, the first enterostomy will be also called hereinbelow as the proximal enterostomy, whereas the second enterostomy willbe also called the distal enterostomy. With reference to a possibleembodiment, the first enterostomy can be a gastrostomy and the secondenterostomy can be a jejunostomy. With reference to a differentembodiment, the first enterostomy can be a proximal jejunostomy and thesecond enterostomy can be a distal jejunostomy.

In accordance with a possible embodiment, the proximal component 26 hasa substantially cylindrical outer structure. A cavity 32 being formed atone of the bases of the cylindrical structure and longitudinallythereto, preferably has a first portion defined by a surface having theshape of a truncated cone 32 a and a second portion defined by acylindrical surface 32 b. The cavity 32 does not run through the entirelength off the proximal component 26, leaving a base wall 34.Furthermore, the cross size of the cavity 32 and the proximal component26 are preferably such as to leave an abutment surface, for example aplane annular surface 26 a contouring the cavity.

According to a possible embodiment, a lug 36, preferably cylindershaped, extends along the longitudinal axis 30 from the bottom of thecavity 32 towards the outside of the cavity, preferably such that a freeend 36 a of the lug 36 is completely out of the cavity 32. In otherwords, the length of the lug 36 from the base of cavity 32 to the freeend 36 a thereof is preferably greater than the depth of the cavity 32.The lug 36 has a preferably cylindrical cavity 38 extending along thelongitudinal axis 30 and crossing the base wall 34 leading to theopposite surface of the proximal component 26. In other words, thecavity 38 involves the lug 36 and base wall 34 thereby generating a ductopen at the ends thereof and suitable to receive a guide wire notillustrated in FIGS. 3-8. Preferably, the proximal component 26comprising the lug 36 is made as one piece.

According to a possible embodiment, the proximal component 26 comprisesholes 40 for example for a suture, which can be used for separating theproximal component from the distal component, to be passed therethrough.

In accordance with a possible embodiment, the distal component 28comprises a head 42 and a stem 44, which are preferably made as onepiece, that develop along the longitudinal axis 30.

The head 42 preferably has a shape of a truncated cone and, according toa possible embodiment, comprises holes 46 for a suture, which can beused for example to separate the distal component from the proximalcomponent, to be passed therethrough.

In accordance with a possible embodiment, the stem 44 preferably has acylindrical structure and a free end thereof, i.e. opposite the head 42,widens to form a preferably annular base 48.

A channel 50 extends along the longitudinal axis 30 from the end of head42 to the base 48 and is suitable to receive a guide wire therein, notillustrated in FIG. 4 or 6. The cross size of channel 50, at least inthe portion at the base 48, are such as to receive the lug 36 of theproximal component 26 therein. In other words, the channel 50 preferablyhas a larger section at the area in which it receives the lug 36.Preferably, the remaining part of channel 50 has the same cross size asthe cavity 38.

FIGS. 3 and 4 illustrate the positioning device 24 when assembled. Theproximal component 26 and the distal component 28 are joined such thatthe cavity 38 and channel 50 define a channel preferably running allalong the assembly for introducing a guide wire, not illustrated inFIGS. 3 and 4. Particularly, FIG. 4 illustrates the positioning device24 sectioned along a plane comprising the longitudinal axis 30. In theassembly position, the proximal component 26 and the distal component 28lock an elastic ring 52 therebetween, which is hold in acompressed/deformed configuration, and suitable to be placed by thepositioning device 24 in a desired anastomotic site in which, after ithas been positioned, the elastic ring 52 takes a preset non-compressedrest shape (see for example FIG. 37). The elastic ring can be made ofNitinol, stainless steel or other satisfying materials.

In accordance with a possible embodiment, the elastic ring 52 in itsdeformed configuration, has an end, such as the proximal (designatedwith numeral 52 a), that is locked between the base 48 of the distalcomponent 28 and the inner diameter of the cavity 32 of the proximalcomponent 26, i.e. inside the cylindrical portion 32 b of the cavity 32.The opposite end of the elastic ring 52, i.e. the distal end designatedwith the numeral 52 b, is preferably unfastened and abuts beneath thehead 42 of the distal component 28. In this case, it is advantageouslyprovided that the cross size of the distal end 52 b of the elastic ring52 does not exceed the cross size of the head 42 of the distal component28.

An exemplary use of the positioning device 24 will be described belowwith particular reference to the FIGS. 34-37. Upon use, the outerdiameter of the proximal component, and particularly with the flatannular surf-ace 26 a, is intended to act as a striker against the wallof the tissue to be drawn together, or in other words, abut against theproximal enterostomy while it minimizes the risk of penetration in thewall.

The distal component 28, with its head 42, is intended to penetrate inthe proximal and distal enterostomies and protects the elastic ring 52while being inserted and positioned, such as will be described in thefollowing.

FIGS. 9-12 illustrate a possible variant embodiment of the positioningdevice 24 and the proximal and distal components thereof according tothe present invention. The elements in common have been designated withthe :same numeral used in FIGS. 3-8 and will be described below withreference to the differences from the above embodiment.

The proximal component 26 is substantially similar to the oneillustrated in FIGS. 3 and 4. As regards the distal component 28, thestem 44 extends straight up to its free end opposite the head 42 thatdoes not widen to form a base similar to the base 48 of the distalcomponent described above. Furthermore, the head 42, preferably havingthe shape of a cone or truncated cone, comprises a flange 54 extendingfrom the outer perimeter of the major base of the head to form acircular wall substantially parallel to the longitudinal axis 30.

FIGS. 9 and 10 illustrate the positioning device 24 when assembled, inwhich the channel 50 and the cavity 38 define a channel extending alongthe longitudinal axis 30 through the entire length of the assembledpositioning device 24 to receive a guide wire, not illustrated in theFIGS. 9-12. In the assembled configuration of the positioning device 24,the elastic ring 52 is hold between the proximal component 26 and thedistal component 28 in a compressed/deformed configuration. After theelastic ring has been positioned, it takes a preset, uncompressed restshape as described above. In the deformed configuration, the proximalend 52 a of the elastic ring 52 is fastened by the inner diameter of thecavity 32, particularly by the cylindrical portion 32 b of the cavity32, whereas the distal end 52 b of the elastic ring 52 is fastenedwithin the circular flange 54 of the distal component 28.

The cross size of channel 50, at least in the portion at the base 48,are such as to receive the lug 36 of the proximal component 26 therein.In other words, the channel 50 has a larger section at the area where itreceives the lug 36. Preferably, the remaining part of channel 50 hasthe same cross size as the cavity 38. Also in this case, the elasticring 52 can be made of Nitinol (Ni—Ti alloy), stainless steel or othersatisfying materials.

The exemplary use of the positioning device is similar throughout thevarious embodiments described.

FIGS. 13-16 illustrate a possible variant embodiment of the positioningdevice and the proximal and distal components thereof according to thepresent invention. The elements in common have been designated with thesame numeral used in the figures above and will be described below withreference to the differences from the above embodiments.

The proximal component 26 has a prismatic outer structure, preferablyhaving a rectangular base. The cavity 32 is formed at one of the basesof the structure and does not run through the entire length of theproximal component 26, leaving a base wall 34. The sizes of the cavity32 and proximal component 26 are such as to leave a peripheral flatsurface 26 a.

In the base wall 34, preferably in the middle thereof, there is provideda preferably cylindrical cavity 38 extending along the longitudinal axis30 and crossing the entire thickness of the base wall.

Ribs 56, preferably on opposite parts of cavity 38 and parallel to thelong sides of the rectangular base, extend from the bottom of the cavity32 by a height preferably less than the depth of cavity 32.

According to a possible embodiment, the proximal component 26 comprisesholes 40 for example for a suture, which can be used for separating theproximal component from the distal component, to be passed therethrough.

The distal component 28 comprises a head 42, which according to apossible embodiment, comprises holes (not illustrated) for a suture,which can be used for example to separate the distal component from theproximal component, to be passed therethrough.

The channel 50 extends along the longitudinal axis 30 throughout thesolid thickness of the head 42, preferably in the middle thereof, and issuitable to receive a guide wire therein, not illustrated in FIG. 14 or15.

The head 42 has a tract having a substantially pyramidal or having atruncated-pyramid shape, preferably with a rectangular base. Two flanges54 that preferably involve the short sides of the rectangular base and alimited portion of the long sides extend from the outer periphery of themajor base of the truncated-pyramidal portion, in a directionsubstantially parallel to the longitudinal axis 30.

According to a possible embodiment, there is provided a preferably flatextension 58, arranged at a middle portion of each long side of therectangular base and projecting in the direction substantially parallelto the longitudinal axis 30 along a preferably longer tract than theflanges 54.

FIGS. 13 and 14 illustrate the positioning device 24 when assembled, inwhich the channel 50 and the cavity 38 are arranged along thelongitudinal axis 30 to receive a guide wire, not illustrated in theFIGS. 13-16. In the assembled configuration of the positioning device24, the elastic ring 52 is hold between the proximal component 26 andthe distal component 28 in a preferably flattened, compressed/deformedconfiguration. After the elastic ring has been positioned, it takes apreset, uncompressed rest shape as described above. In the deformedconfiguration, the proximal end 52 a of the elastic ring 52 is fastenedby the inner periphery of the cavity 32. Particularly, the ribs 56fasten the elastic ring 52 in a flat deformed configuration, or in otherwords, the elastic ring 52 is arranged between the wall of the cavity 32and the ribs 56. Furthermore, the distal end 52 b of the elastic ring 52is fastened by the flanges 54 and extensions 58, when the latter areprovided.

On the one hand, the assembled configuration of the positioning device24 is ensured by the interference between the proximal end 52 a of theelastic ring 52 and the walls of the proximal component 26 defining thecavity 32, and on the other hand by the interference between the distalend 52 b of the elastic ring 52 and the flanges 54 and the extensions58, when the latter are provided.

Also in this case, the elastic ring 52 can be made of Nitinol, stainlesssteel or other satisfying materials.

The exemplary use of the positioning device is similar throughout thevarious embodiments described. In this latter case, the peripheral wall26 a of the proximal component 26 is the one intended to abut againstthe wall of the tissue to be drawn together while minimizing the riskthat the wall may be penetrated. Furthermore, the angled head 42 of thedistal component 28 is intended to penetrate the proximal and distalenterostomies and protects the elastic ring 52 when being introduced andpositioned by fastening the ring within the flanges 54 and theextensions 58, such as will be described in the following.

The channel 50 and the cavity 38 are intended to house a guide wire fortransporting the positioning device.

The present invention further relates to a method for the therapy ofobesity and particularly a method for carrying out anastomosis in tractsof the digestive tube. FIGS. 17-40 illustrate several steps of apossible embodiment of the method according to the present invention.The examples illustrated particularly relate to a method for carryingout an endoluminal/transluminal gastrojejunostomy (G-J) and ajejunojejunostomy (J-J) via transoral access.

In general terms, the method according to the present inventionadvantageously provides to draw tissues together and carry outanastomosis via endoluminal access by introducing, through a naturalorifice (such as nose, mouth, ears, anus) or other luminal structures,guide or rail means within the tissues to be drawn together. Suitablecomponents or devices can be thereby carried to the anastomotic sitesuch that the surfaces of the tissues are suitably drawn together andconnected with a channel (anastomosis).

Advantageously, the guide or rail means, particularly a main guide wireor first guide wire, are introduced such as to generate an open ringthat can begin and end in natural orifices, such as the mouth, nose,anus or other natural orifices, such as colostomy, trocar, abdomenincisions, wounds, fistulae. The components or devices provided to drawthe tissues together are advantageously moved by locking the device onthe guide wire and pulling one of the guide wire ends.

In accordance with a possible embodiment, the ends of the open ring andaccordingly of the main guide wire are different from each other, andhence distinguishable. Advantageously, the guide wire is internallyhollow, i.e. it has a tubular structure suitable to receive needles forperforating the tissues and carrying out proximal and distalenterostomies. Perforation can take place for example either by pushingthe needle through the tissues, or applying a radiofrequency through theneedle.

The open ring then crosses the proximal enterostomy and then the distalenterostomy, for example by using a gripping device.

The positioning device 24 is locked on the guide wire by means of ananchoring ring 76 and drawn by the guide wire until it is partiallyinserted in the proximal enterostomy and abutted against a first tissueportion to be joined. The positioning device 24 is further drawn untilit is partially inserted in a distal enterostomy by drawing together thetissue portions to be joined. Finally, the positioning device 24partially inserted in the proximal and distal enterostomy releases anelastic ring 52 riding the proximal and distal enterostomies to hold thetissue portions joined to each other thereby generating a passage oranastomosis.

With reference to the above example, FIGS. 17-29 illustrate agastrojejunostomy (G-J) step that is advantageously carried out byintroducing guide ox rail means through a natural orifice (such as thenose or mouth). Subsequently, the guide means, a guide wire in thiscase, form an open ring crossing the points of the tissues to be joined.

FIG. 17 illustrates a first step, which is designated as the step 1, inwhich a substantially conventional laparoscope 60 has been introduced inthe abdominal cavity to view the areas to be treated. This step can bepotentially eliminated after a certain degree of skill in the method hasbeen achieved, thereby the method can be made completely endoluminal andtransluminal. The laparoscope 60 is illustrated in FIG. 17 and also inthe subsequent steps, but it can be omitted as well. Alternatively or inaddition to the laparoscopic control, a gastroscopic control can beprovided, i.e. by introducing a secondary gastroscope for examplethrough the esophagus or mouth having the function of controlling themethod steps. In case a gastroscope is required to carry out severalsteps of the method, a main gastroscope carrying out the method stepsand a secondary gastroscope monitoring the operation will be introduced.

FIG. 18 illustrates a step of the method according to the presentinvention, which is also designated as the step 2, in which asubstantially conventional main gastroscope 62 is introduced through theesophagus, stomach, passing through the pylorus and subsequently theduodenum to reach the jejunum. Particularly, the gastroscope 62 isadvanced by approximatively 20-40 cm beyond the pylorus.

FIG. 19 illustrates a detail of the jejunum and the end of thegastroscope 62. The latter conventionally comprises several channels 64crossing the entire length thereof and that can be used for tools or thelike to be passed therethrough. The step from FIG. 19, also designatedas the step 3, provides that a first guide wire 66 or main guide wirebeing suitable to provide the open ring is advanced along one of thechannels 64 of the gastroscope 62. The guide wire is advanced until apointed end 66 a thereof or a needle sliding along the tubular structureof the guide wire protrudes from the gastroscope. The end 66 a of theguide wire 66 perforates the jejunum wall from the inside and creates ajejunostomy (proximal enterostomy). The laparoscope 60 is optionallyprovided. When this is provided, the guide wire 66 is advanced and thejejunostomy is created under the laparoscope visual control.

The jejunostomy can be carried out by pushing the guide wire directlythrough the jejunum wall. Alternatively, or in addition thereto,radiofrequency energy may be applied to perforate the jejunum wall andthen advance the guide wire 66.

In other words, a first guide wire 66 being part of guide or rail meanswhich will be subsequently indicated in greater detail, is positionedwithin the tissue to be joined and passed through one of the tissueportions to be joined. The jejunum tissue portion to be drawn near andjoined to the stomach thereby forming an anastomosis has been designatedwith A.

FIG. 20 illustrates a step which has been designated as the step 4 inwhich the gastroscope 62 is removed and the guide wire 66 is left in theabdomen within the stomach and along a jejunum tract with the end 66 aprotruding from the jejunum at the tissue portion A to be joined. Thestep 4 can be carried out under laparoscopic control (laparoscope 60),when provided.

FIG. 21 illustrates a step which is designated as the step 5, in which amain gastroscope 62, of a substantially conventional type, has beenintroduced again in the stomach through the esophagus, in order tocreate a gastrostomy (distal enterostomy). Also in this case, one maydirectly push either a secondary guide wire 77 with a pointed end 77 aor a needle sliding within the tubular structure of the guide wire.Alternatively, or in addition thereto, radiofrequency energy can beapplied in order to perforate the stomach wall and advance the guidewire.

The gastrostomy is carried out in a stomach portion corresponding to thearea to be joined. This portion has been designated with A′.

Step 5 may also be carried out under laparoscopic control.

FIG. 22 illustrates a step of the method according to the presentinvention, which has been designated as the step 6, in which thegastrostomy is enlarged by means of a balloon catheter 72. The catheteris inserted in the gastroscope 62 until a balloon-end 72 a thereofreaches the gastrostomy which is enlarged by inflating the balloon.

Step 6 may also be carried out under laparoscopic control.

FIG. 23 illustrates a step of the method according to the presentinvention, which has been also designated as the step 7, in which thegastroscope 62 is advanced through the gastrostomy enlarged by theballoon, within the abdominal cavity. Step 7 can be carried out eitherunder gastroscopic (secondary gastroscope) and/or laparoscopic(laparoscope 60) control. As stated above, by gastroscopic control ismeant a control carried out by means of a secondary gastroscope, notillustrated in FIG. 23, which is introduced through the esophagus havingonly a control function. This secondary gastroscope can be provided inevery step whenever a gastroscopic control as an alternative or inaddition to the laparoscopic control is required.

FIG. 24 illustrates a step which has been designated as the step 8, inwhich a gripping device 74 (forceps or the like) is advanced through thegastroscope 62 and the end 66 a of the guide wire 66 protruding from thejejunostomy is coupled therethrough. Gripping the guide wire point isnot required.

The gripping device 74 can be for example a loop-shaped endoscopicinstrument for polypectomies.

FIG. 25 illustrates a step which has been designated as the step 29, inwhich the guide wire 66 of the jejunum is pulled through the gastrostomyin order to provide a first ring 80 open at the ends thereof, orgastro-jejunum ring (ring 1), the ends thereof protruding from theorifice used (the mouth, esophagus, . . . ). In FIG. 25, the end of ring80 corresponding to the jejunum (jejunum end), i.e. the end passingthrough the stomach and jejunum and protruding from portion A has beendesignated with 80 a, whereas the end of the ring 80 corresponding tothe stomach (stomach end), i.e. the end passing through the stomach andprotruding therefrom at portion A′ has been designated with 80 b. Bothends are advantageously different from each other in order to bedistinguished.

The ring 80 can be now used as a guide means or rail system in order tointroduce and carry suitable anastomotic devices suitable to draw thetissues together and carry out the anastomosis in the site of interest.The anastomotic devices are advantageously locked on the guide wire forexample by means of an anchoring ring 76 and one of the ends of the ringis pulled until the anastomotic device partially enters the proximalenterostomy, draws the tissues thereof near the distal enterostomy andpartially enters the same.

FIG. 26 illustrates a step which has been designated as the step 10,wherein the selected anastomotic device (anvil 16, positioning device24, etc.) is inserted on the guide wire from the jejunum end 80 a andpulled along the ring 80 of guide wire through the esophagus, stomach,duodenum and jejunum. Drawing is allowed by an anchoring ring 76 whichis made integral with the guide wire such as to push against theproximal part of the selected anastomotic device.

Though an anvil 16 has been illustrated in FIG. 26, a positioning device24 or other similar devices can be used as well.

By pulling the guide wire from the end of stomach 80 b, the anastomoticdevice can be pulled until the portion A of the jejunum (proximalenterostomy).

As illustrated in FIG. 26, the end of the jejunum part of the guide wire80 a is inserted in the channel 22 of the anvil 16 from the side of thestem 18. In the case of the positioning device 24, the end of thejejunum part of the guide wire 80 a would be inserted in the channel 50from the side of the distal component 28.

FIG. 27 illustrates a step which has been also designated as the step11, in which the anastomotic device and particularly the anvil 16 ispulled until it has partially passed the jejunostomy (proximalenterostomy). As already stated above, one can act under laparoscopiccontrol. The stem 18 of the anvil 16 crosses the jejunostomy andprotrudes in the abdominal cavity, whereas the head 20 contacts thetissue to be drawn together. When a positioning device 24 is used, thehead would enter the jejunostomy whereas the flat peripheral surface 26a would abut against the contouring tissues.

FIG. 28 illustrates a step which has been also designated as the step12, in which by keeping on pulling the end of the guide wire 80 b fromthe side of the stomach, the anvil 16 and particularly the head 20 actsas a striker against the inner wall of the portion A of the jejunum anddraws the jejunum until the portion A is drawn near the stomach andparticularly portion A′. The stem 18 of the anvil 16 (anastomoticdevice) also partially enters the gastrostomy (distal enterostomy). Theoperation can be carried out under laparoscopic control (laparoscope60). When a positioning device 24 is used, the head would 42 enter thegastrostomy whereas the flat peripheral surface 26 a would draw therelative contouring tissues together.

FIG. 29 illustrates a step which has been indicated as the step 13, inwhich the traction on the stomach end 80 b of the guide wire ismaintained in order to maintain the portions A and A′ near each other.Furthermore, a circular stapler 10 is caused to slide on the guide wirefrom the stomach end 80 b until it reaches the inside of the stomach,and until the stem 18 of the anvil 16 connects to the end of the stem 14of the stapler 10 (such as illustrated in greater detail in FIGS. 2 aand 41-44). The stapler 10 carries out the anastomosis between theportion A and the portion A′ by cutting and suturing the tissue in acircular manner. A passage 84 is thereby formed (FIG. 30) which directlycommunicates the stomach and jejunum. When a positioning device 24 isused, the passage 84 is obtained by detaching the proximal componentfrom the distal component and releasing the elastic ring 52 riding bothenterostomies.

When the gastrojejunostomy (G-J) has been completed, the guide wire 66is removed by drawing one end thereof.

With reference to the above example, FIGS. 30-40 illustrate ajejunojejunostomy (J-J) step that is advantageously carried out byintroducing guide or rail means through a natural orifice (such as theesophagus or mouth). Subsequently, the guide means, a guide wire in thiscase, form an open ring crossing the points of the tissues to be joined.

FIG. 30 illustrates a step designated as the step 14, in which asubstantially conventional gastroscope 62 is introduced through theesophagus, stomach, passing through the pylorus and subsequently theduodenum to reach the jejunum. Particularly, the gastroscope 62 isadvanced to a portion to be joined that is designated with B in order tocarry out a proximal jejunostomy, which portion is proximally arrangedrelative to channel 84 (anastomosis) that has already been created.

A guide wire 86, or main guide wire, intended to form the open ring isadvanced along a channel 64. The guide wire is advanced until a pointedend 86 a thereof or a needle sliding within the guide wire protrudesfrom the gastroscope. The end 86 a of the guide wire 66 perforates thejejunum wall from the inside and creates a jejunostomy (proximalenterostomy).

The laparoscope 60 is optionally provided. When this is provided, theguide wire 86 is advanced and the jejunostomy is created under thelaparoscope visual control.

The jejunostomy can be carried out by pushing the guide wire directlythrough the jejunum wall. Alternatively, or in addition thereto,radiofrequency energy may be applied to perforate the jejunum wall andthen advance the guide wire 86.

In other words, a guide wire 86 being part of guide or rail means whichwill be subsequently indicated in greater detail, is positioned withinthe tissue to be joined and passed through one of the tissue portions Bto be joined (proximal jejunostomy).

FIG. 31 illustrates a step which has been indicated as the step 15, inwhich the gastroscope 62 is removed and the guide wire 86 is left withinthe stomach and jejunum, with the end 86 a protruding from the walls ofthe jejunum (proximal jejunostomy). The gastroscope 62 is then advancedthrough the stomach, the previously accomplished gastrojejunostomy (step84) and a tract of the distal jejunum until a sufficient distance tocreate the jejunumjejunum (J-J) anastomosis. The latter portion has beenindicated with the reference B′. Analogously to FIGS. 21 and 22 (steps 5and 6) a secondary guide wire is advanced along the gastroscope 62 untila pointed end thereof protrudes from the end of the gastroscope 62. Thispointed end is then passed through the tissue walls at the portion B′ inorder to create a distal jejunostomy. The distal jejunostomy can be alsocarried out either by directly pushing the pointed end through thejejunum wall or applying radiofrequency energy in order to perforate thewall, subsequently advancing the guide wire.

The creation of the distal jejunostomy can be monitored through thelaparoscope.

A catheter with balloon-end may be optionally inserted along thegastroscope. When the balloon end is near the distal jejunostomy, theballoon is inflated in order to dilate the distal jejunostomy and thegastroscope is pushed in the abdominal cavity. This dilation may berequired when the laparoscope is not used and monitoring is carried outthrough the gastroscope such that the latter can view the end 86 a ofthe guide wire 86.

FIG. 32 illustrates a step which has been designated as the step 16, inwhich a gripping device 74 (endoscopic forceps or the like) similar tothe one used in step 8, is advanced through the gastroscope to lock theend 86 a of the main guide wire 86 protruding from the proximaljejunostomy site. Gripping the guide wire end is not required.

FIG. 33 illustrates a step which has been indicated as the step 17, inwhich the gastroscope has been removed and the main guide wire 86 hasbeen pulled through the distal jejunostomy to form a ring 88 open at theends thereof, or jejunumjejunum ring (the ring 2), the ends thereofprotruding from the orifice used. In FIG. 33 the end of the jejunum,i.e. the end passing through the stomach and the jejunum and protrudingtherefrom at portion B has been designated with 88 a, whereas the end ofthe stomach, i.e. the end passing through the stomach, protruding fromthe gastrojejunostomy (passage 84) and protruding from the jejunum atportion B′ has been designated with 88 b.

The ring 88 can be now used as a guide means or rail system in order tointroduce and carry suitable anastomotic devices suitable to draw thetissues together and carry out the anastomosis in the site of interest(J-J). As described above, the anastomotic device is locked on the guidewire, an end thereof being pulled in order to advance the anastomoticdevice.

FIG. 34 illustrates a step which has been designated as the step 18,wherein an anastomotic device such as a positioning device 24 isinserted from the jejunum end 88 a and pulled along the ring 88 of guidewire through the esophagus, stomach, duodenum and jejunum. The operationmay be carried out under laparoscopic and/or gastroscopic control inorder to view the movement.

The anastomotic device may be caused to slide on the guide wire from thejejunum end 88 a. Traction is permitted due to an anchoring ring similarto that described above, which is made integral with the guide wirepushing against the proximal part of the selected anastomotic device. Bypulling the guide wire from the end of stomach 88 b, the anastomoticdevice can be pulled until the portion B of the jejunum.

As illustrated in FIG. 34, the positioning device 24 (channel 50 andcavity 38) is inserted on the end 88 a of the guide wire from the sideof the distal component 28.

The anastomotic device and particularly the positioning device 24 ispulled until it has partially passed the proximal jejunostomy. The head42 of the distal component 28 and a part of the elastic ring 52 crossthe proximal jejunostomy and protrude in the abdominal cavity, whereasthe other part of the elastic ring 52 remains within the jejunum. Theproximal component also remains within the jejunum and abuts, forexample with the surface 26 a, against the tissue wall to act as astriker.

FIG. 35 illustrates a step which has been designated as the step 19, inwhich the two jejunum branches are drawn together, optionally undergastroscopic and/or laparoscopic vision by keeping on pulling theanastomotic device (positioning device 24).

Particularly, the head 42 of the distal component 28 with a part of theelastic ring 52 penetrate in the distal jejunostomy.

FIG. 36 illustrates a step which has been designated as the step 20, inwhich the elastic ring 52 that takes its uncompressed configuration,such as illustrated enlarged for example in FIG. 37 (step 21) ispositioned. The ends of the elastic ring 52 fold between the proximaljejunostomy and the distal jejunostomy thereby maintaining the portion Band portion B′ joined to each other thereby creating a circularanastomosis. The elastic ring 52 can be released from the positioningdevice 24 by simultaneously uncoupling the distal and proximalcomponents 26 and 28. Alternatively, one of the two components can beuncoupled by pulling the same while keeping unchanged the position ofthe elastic ring 52 relative to the anastomotic site.

To uncouple the distal component and the proximal component, one can usethe suture threads protruding from the holes 40 of the proximalcomponent 26 and the holes 46 of the distal component 28 by couplingthem by means of a suitable tool inserted in a gastroscope 62. Thesuture stitches are thus gripping points for uncoupling the proximal anddistal components of the positioning device 24 from each other.

During positioning, the enterostomy can be viewed by means of agastroscope or laparoscope.

When the jejunojejunostomy (J-J) has been completed, the guide wire 86is removed by drawing one end thereof.

FIG. 38 illustrates a step which has been designated as the step 22, inwhich the gastrojejunostomy (G-J) and the jejunojejunostomy (J-J) havebeen completed and in which there is illustrated the route followed bythe food along the digestive tract after it has been changed.

To complete the method discussed above, either a gastric partitionobtained with a gastric bandage such as illustrated in FIG. 39 (step23.1) or a gastric partition obtained with an endoscopic stapler such asillustrated in FIG. 40 (step 23.2) can be provided.

From what has been described above, one may appreciate how the provisionof guide means carrying components or devices to the desired anastomoticsite through natural orifices (such as the nose, mouth, ear, anus) orother luminal structures in order to carry out anastomosis greatlysimplifies the procedure, shortens the patient's convalescence andeliminates the drawbacks of traditional surgery.

The provision of components and devices that suitably draw the tissuesurfaces together and/or connect the surfaces by means of a passage isparticularly advantageous and allows to carry out a completelyendoluminal method.

It should be understood that variations and/or additions to what hasbeen described and illustrated above may be provided.

In addition to the method described above, there may providedalternative procedures (ERCP, Chole duct, coloproctostomy,jejunum-colostomy).

The order of the steps of the method illustrated in the annexed drawingsand described above, (gastrojejunostomy or G-J, jejunojejunostomy orJ-J, sectioning) can be readapted. For example, with patients that havealready been subjected to gastric bandage, the steps G-J and J-J can becompleted as described above. Subsequently, the gastric bandage can becompletely restricted by carrying out a gastric partition therebycompleting the procedure.

Alternatively to the use of the circular stapler 10 and anvil 16, thegastrojejunostomy G-J according to the steps described above (FIG.17-FIG. 29) can be carried out by means of a positioning device 24 asdescribed above (similarly to the jejunojejunostomy J-J stepscorresponding to FIGS. 31-38).

To the preferred embodiment of the device, stapler or method describedabove, those skilled in the art, aiming at satisfying contingent andspecific requirements, may carry out a number of modifications,adaptations and replacement of elements with others functionallyequivalent, without however departing from the scope of the claimsbelow.

What is claimed is:
 1. A method for carrying out anastomosis in tractsof the digestive tube comprising the steps of: perforating first andsecond portions of tissues intended to be approximated and joined byanastomosis; introducing a guide or rail means through the perforationsin the first and second portions of tissues, through a natural orificeor other luminal structures, providing a positioning device comprising aproximal component and a distal component, wherein said proximal anddistal components are detachably connected to each other and block anelastic tubular ring in a compressed deformed configurationtherebetween, inserting the positioning device along the guide means anddrawing the positioning device to the anastomotic site by pulling theguide means, introducing the distal component of the positioning devicein the perforation of the first portion of tissue by pulling said guidemeans, abutting the proximal component of the positioning device againstthe first portion of tissue by pulling said guide means, approximatingthe first and second portions of the tissues by pulling said guidemeans, wherein the proximal component of the positioning device acts asa striker which draws the first portion of tissue to the second portionof tissue, introducing the distal component of the positioning device inthe perforation of the second portion of tissue by pulling said guidemeans, carrying out an anastomosis by detaching said proximal and distalcomponents from each other to release the elastic ring from saidproximal and distal components and to have the ring take a rest shape inwhich ends of the ring are folded in a manner to hold the approximatedportions of tissue together for generating the anastomosis.
 2. Themethod according to claim 1, wherein the step of introducing the guideor rail means includes a step of using a main guide wire as said guideor rail means and generating an open ring with the ends matchingorifices and being such as to cross the portions of the tissues to bejoined.
 3. The method according to claim 2, further comprising a step ofcrossing the ring-shaped guide wire with a proximal enterostomy and adistal enterostomy, said enterostomies being obtained by causing aneedle to slide within a tubular structure of a guide wire.
 4. Themethod according to claim 3, further comprising the step of advancingthe main guide wire suitable to be ring-shaped until it matches thefirst portion of the tissue to be joined, and inserting the main guidewire through a proximal enterostomy by causing the needle to slidewithin the tubular structure of said main guide wire.
 5. The methodaccording to claim 4, further comprising a step of advancing a secondaryguide wire having a tubular structure until matching the second portionof the tissue to be joined and carrying out a distal enterostomy bycausing a needle to slide within a tubular structure of said secondaryguide wire.
 6. The method according to claim 5, further comprising thestep of advancing a gripping device through said distal enterostomy andgripping the end of the main guide wire suitable to be ring-shaped anddraw the same to obtain said open ring.
 7. The method according to claim2, further comprising steps of advancing and locking the positioningdevice on the main guide wire defining the open ring and drawn bypulling one of the free ends of the open ring.
 8. The method accordingto claim 1, further comprising a step of advancing the positioningdevice until it is partially introduced in a proximal enterostomythereby abutting against a first portion to be joined.
 9. The methodaccording to claim 8, further comprising the step of further advancingthe positioning device until it is partially introduced in a distalenterostomy by drawing near the portions of the tissues to be joined.10. The method according to claim 9, further comprising a step ofpartially inserting the positioning device into the proximal and distalenterostomies and releasing an elastic ring to hold the tissue portionsjoined to each other thereby generating a passage.
 11. The methodaccording to claim 1, further comprising a step of carrying out agastrojejunostomy comprising the steps of: introducing the guide or railmeans through a natural orifice or other orifice within the stomach andjejunum, and shaping the guide means in a first open ring with endsleading to said orifice, said first ring crossing the portions to bejoined.
 12. The method according to claim 11, wherein the step ofintroducing the guide or rail means within the stomach and jejunumcomprises a step of advancing a main guide wire through the esophagus,stomach and a tract of the jejunum and passing an end thereof throughthe jejunum wall forming a jejunostomy.
 13. The method according toclaim 12, wherein the jejunostomy is carried out by causing a needle toslide within the main guide wire which has a tubular structure.
 14. Themethod according to claim 11, further comprising a step of creating agastrostomy at a portion of the tissue of the stomach to be joined tothe corresponding portion of the jejunum.
 15. The method according toclaim 14, further comprising a step of creating a gastrostomy by aneedle that is slidingly inserted in a tubular structure of a secondaryguide wire.
 16. The method according to claim 14, further comprising astep of enlarging said gastrostomy.
 17. The method according to claim14, further comprising a step of advancing a gripping device through thegastrostomy and coupling it to the end of the main guide wire protrudingfrom the jejunostomy.
 18. The method according to claim 1, comprising astep of carrying out a jejunostomy comprising the steps of: introducingthe guide or rail means through a natural orifice or other orificewithin the stomach and jejunum, and shaping the guide means in an openring with ends leading to said orifice, said ring crossing the portionsto be joined, respectively a proximal jejunostomy and a distaljejunostomy.